Real World Data Study Assessing The Persistency Of Xalacom And The Other Fixed Dose Combination Products, Duotrav And Ganfort, In The United Kingdom

Glaucoma Clinical Trial

Official title:

Persistence Of Use Of Topical Prostaglandin Fixed Dose Combination In The United Kingdom Primary Care: An Observational Study In Thin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01206361
• Other study ID #: A6111145
• Status: Completed
• Start date: February 2010
• Est. completion date: August 2010

Study information

• Verified date: June 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The hypothesis is that there is no difference in persistency between Xalacom and the alternative fixed dose combination products (Duotrav and Ganfort) over a 12 month period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2015
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Patients who had received a prescription for either Xalacom, Ganfort and DuoTrav

• Greater than 18 years old

• Diagnosed with glaucoma or ocular hypertension

• Registered at the primary care practice for > 12 months

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Glaucoma
• Ocular Hypertension

Intervention

Drug:
• XALACOM
Xalacom eye drops
• Duotrav
Duotrav eye drops
• Ganfort
Ganfort eye drops

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency distribution of persistent and non-persistent patients across study cohorts		12 months
Primary	Frequency distribution of switchers, re-starters and discontinuing patients as well as patients commencing add-on therapy across the study cohorts		12 months
Primary	Time to discontinuation of each cohort		12 months
Secondary	Age and sex: Townsend Score of social deprivation, time since first THIN diagnosis of glaucoma or ocular hypertension		12 months
Secondary	Procedures: Laser, Trabeculectomy, viscocanalostomy, deep sclerectomy		12 months
Secondary	Ocular Pharmacological Treatments: Beta-blockers and Alpha-agonists		12 months
Secondary	Prostaglandin mono-therapies		12 months
Secondary	The cohort of patients which were evaluated in this study were investigated for the presence of history of disease for asthma, cardiovascular disease, diabetes, renal failure and systemic hypertension. The number of patients in each cohort were		12 months
Secondary	presented who had had (i) a 12 month history of any of the diseases or (ii) had had a history of any of the diseases.		12 months

External Links

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